JP5800829B2 - Ｃｏｐｄ用エアロゾル製剤 - Google Patents

Ｃｏｐｄ用エアロゾル製剤 Download PDF

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Publication number
JP5800829B2
JP5800829B2 JP2012545322A JP2012545322A JP5800829B2 JP 5800829 B2 JP5800829 B2 JP 5800829B2 JP 2012545322 A JP2012545322 A JP 2012545322A JP 2012545322 A JP2012545322 A JP 2012545322A JP 5800829 B2 JP5800829 B2 JP 5800829B2
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JP
Japan
Prior art keywords
composition according
pharmaceutical composition
glycopyrronium bromide
canister
per actuation
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Active
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JP2012545322A
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English (en)
Japanese (ja)
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JP2013515695A (ja
Inventor
サウロ ボネッリ、
サウロ ボネッリ、
フランチェスカ ウスベルティ、
フランチェスカ ウスベルティ、
エンリコ ザンベッリ、
エンリコ ザンベッリ、
Original Assignee
シエシー ファルマセウティチィ ソシエタ ペル アチオニ
シエシー ファルマセウティチィ ソシエタ ペル アチオニ
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Application filed by シエシー ファルマセウティチィ ソシエタ ペル アチオニ, シエシー ファルマセウティチィ ソシエタ ペル アチオニ filed Critical シエシー ファルマセウティチィ ソシエタ ペル アチオニ
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/04—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied
    • B65B31/06—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied the nozzle being arranged for insertion into, and withdrawal from, the mouth of a filled container and operating in conjunction with means for sealing the container mouth
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/10—Adding propellants in solid form to aerosol containers

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dispersion Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Mechanical Engineering (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2012545322A 2009-12-23 2010-12-22 Ｃｏｐｄ用エアロゾル製剤 Active JP5800829B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09015980 2009-12-23
EP09015980.7 2009-12-23
PCT/EP2010/070478 WO2011076842A2 (fr) 2009-12-23 2010-12-22 Préparation aérosol pour copd (bronchopneumopathie chronique obstructive)

Publications (2)

Publication Number Publication Date
JP2013515695A JP2013515695A (ja) 2013-05-09
JP5800829B2 true JP5800829B2 (ja) 2015-10-28

Family

ID=42046446

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2012545322A Active JP5800829B2 (ja) 2009-12-23 2010-12-22 Ｃｏｐｄ用エアロゾル製剤

Country Status (31)

Country Link
US (4) US20110150783A1 (fr)
EP (1) EP2515854B1 (fr)
JP (1) JP5800829B2 (fr)
KR (1) KR101747474B1 (fr)
CN (1) CN102665680B (fr)
AU (2) AU2010334858A1 (fr)
CA (1) CA2785317C (fr)
CL (1) CL2012001668A1 (fr)
CO (1) CO6551734A2 (fr)
CY (1) CY1115109T1 (fr)
DK (1) DK2515854T3 (fr)
EA (1) EA021604B1 (fr)
ES (1) ES2464520T3 (fr)
GE (1) GEP20166479B (fr)
HK (1) HK1174568A1 (fr)
HR (1) HRP20140550T1 (fr)
IL (1) IL220534A0 (fr)
MA (1) MA33821B1 (fr)
MX (1) MX340264B (fr)
MY (1) MY156950A (fr)
NZ (1) NZ600789A (fr)
PE (1) PE20121467A1 (fr)
PL (1) PL2515854T3 (fr)
PT (1) PT2515854E (fr)
RS (1) RS53355B (fr)
SG (1) SG181870A1 (fr)
SI (1) SI2515854T1 (fr)
TN (1) TN2012000261A1 (fr)
UA (1) UA106098C2 (fr)
WO (1) WO2011076842A2 (fr)
ZA (1) ZA201204613B (fr)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG181870A1 (en) 2009-12-23 2012-07-30 Chiesi Farma Spa Aerosol formulation for copd
BR112012015334A2 (pt) * 2009-12-23 2016-03-15 Chiesi Farma Spa terapia combinada para doença pulmonar obstrutiva crônica
EP2515855B3 (fr) * 2009-12-23 2023-05-03 Chiesi Farmaceutici S.p.A. Polythérapie pour la COPD
PL3096737T3 (pl) * 2013-12-30 2018-08-31 Chiesi Farmaceutici S.P.A. Stabilna kompozycja w postaci ciśnieniowego roztworu aerozolowego kombinacji bromku glikopironium i formoterolu
EP3384898A1 (fr) 2013-12-30 2018-10-10 Chiesi Farmaceutici S.p.A. Composition de solution d'aérosol sous pression stable de combinaison de bromure de glycopyrronium et de formotérol
EP3383366B2 (fr) 2015-12-04 2024-06-05 Mexichem Fluor S.A. de C.V. Composition pharmaceutique
EP3515432B1 (fr) * 2016-09-19 2021-08-25 Mexichem Fluor S.A. de C.V. Composition pharmaceutique comprenant glycopyrrolate
WO2020084549A1 (fr) * 2018-10-25 2020-04-30 Glenmark Specialty S.A. Composition de nébulisation comprenant du glycopyrrolate et du formotérol
BR112023001689A2 (pt) 2020-07-31 2023-05-02 Chemo Res S L Terapia de combinação para administração por inalação
CN112051346A (zh) * 2020-09-24 2020-12-08 珠海瑞思普利生物制药有限公司 一种同时测定茚达特罗和格隆溴铵含量的hplc方法
CA3193038A1 (fr) 2020-10-09 2022-04-14 Enrico Zambelli Formulation pharmaceutique pour inhalateur doseur pressurise
WO2023227781A1 (fr) 2022-05-27 2023-11-30 Chiesi Farmaceutici S.P.A. Formulation pharmaceutique pour aérosol-doseur sous pression

Family Cites Families (26)

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Publication number Priority date Publication date Assignee Title
US2956062A (en) 1959-02-26 1960-10-11 Robins Co Inc A H Esters of amino alcohols
KR100312357B1 (ko) 1992-12-09 2002-04-24 데이비드 이. 프랭크하우저 안정화된약제의에어로졸용액제제
US6475467B1 (en) 1998-08-04 2002-11-05 Jago Research Ag Medicinal aerosol formulations
IT1317720B1 (it) 2000-01-07 2003-07-15 Chiesi Farma Spa Dispositivo per la somministrazione di aerosol dosati pressurizzati inpropellenti idrofluoroalcani.
GB0008660D0 (en) 2000-04-07 2000-05-31 Arakis Ltd The treatment of respiratory diseases
US20060257324A1 (en) * 2000-05-22 2006-11-16 Chiesi Farmaceutici S.P.A. Pharmaceutical solution formulations for pressurised metered dose inhalers
ME00220B (me) * 2000-05-22 2010-10-10 Chiesi Farm Spa Stabilne farmaceutske formulacije rastvora za inhalatore odmjerene doze pod pritiskom
NZ528640A (en) * 2001-03-30 2004-06-25 Jagotec Ag Medical aerosol formulations
US6667344B2 (en) 2001-04-17 2003-12-23 Dey, L.P. Bronchodilating compositions and methods
EP1321159A1 (fr) 2001-12-21 2003-06-25 CHIESI FARMACEUTICI S.p.A. Dispositif d'actionnement pour inhalateur doseur pressurisé avec orifices percés par laser
ME00077B (fr) 2002-03-01 2010-06-10 Chiesi Farm Spa Preparation superfine de formoterol
CA2510043A1 (fr) 2002-12-16 2004-07-01 Boehringer Ingelheim Pharma Gmbh & Co. Kg Formulations de solutions aux hfc contenant du tiotropium
WO2005074900A2 (fr) 2004-02-06 2005-08-18 Meda Pharma Gmbh & Co. Kg Nouvelle combinaison d'anticholinergique et de beta-mimetiques pour le traitement de maladies respiratoires
GB0410399D0 (en) 2004-05-10 2004-06-16 Arakis Ltd The treatment of respiratory disease
GB0613161D0 (en) * 2006-06-30 2006-08-09 Novartis Ag Organic Compounds
EP1894568A1 (fr) 2006-08-31 2008-03-05 Novartis AG Composées pharmaceutiques destinées au traitement des maladies inflammatoires ou obstructives des bronches
CA2702830C (fr) 2007-10-18 2017-02-28 Stiefel Research Australia Pty Ltd Formulations topiques de glycopyrrolate
EP2440196A4 (fr) * 2009-06-09 2013-01-02 Elevation Pharmaceuticals Inc Traitement d'une maladie pulmonaire obstructive chronique par administration de bêta 2 agoniste nébulisé ou d'une combinaison de bêta 2 agoniste nébulisé et d'anticholinergique
EP2515856B1 (fr) 2009-12-23 2014-04-02 Chiesi Farmaceutici S.p.A. Formule d'aérosol pour COPD
BR112012015334A2 (pt) 2009-12-23 2016-03-15 Chiesi Farma Spa terapia combinada para doença pulmonar obstrutiva crônica
EP2515855B3 (fr) * 2009-12-23 2023-05-03 Chiesi Farmaceutici S.p.A. Polythérapie pour la COPD
SG181870A1 (en) * 2009-12-23 2012-07-30 Chiesi Farma Spa Aerosol formulation for copd
RU2578975C2 (ru) * 2010-08-03 2016-03-27 КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. Фармацевтический препарат, содержащий ингибитор фосфодиэстеразы
GB201200525D0 (en) 2011-12-19 2012-02-29 Teva Branded Pharmaceutical Prod R & D Inc An inhalable medicament
PL3096737T3 (pl) * 2013-12-30 2018-08-31 Chiesi Farmaceutici S.P.A. Stabilna kompozycja w postaci ciśnieniowego roztworu aerozolowego kombinacji bromku glikopironium i formoterolu
EP3384898A1 (fr) 2013-12-30 2018-10-10 Chiesi Farmaceutici S.p.A. Composition de solution d'aérosol sous pression stable de combinaison de bromure de glycopyrronium et de formotérol

Also Published As

Publication number Publication date
ES2464520T3 (es) 2014-06-03
WO2011076842A3 (fr) 2011-12-01
GEP20166479B (en) 2016-05-25
RS53355B (en) 2014-10-31
CY1115109T1 (el) 2016-12-14
EP2515854B1 (fr) 2014-03-19
US20230157951A1 (en) 2023-05-25
ZA201204613B (en) 2013-09-25
AU2010334858A1 (en) 2012-07-12
US11590074B2 (en) 2023-02-28
PT2515854E (pt) 2014-05-27
SI2515854T1 (sl) 2014-07-31
KR20120120160A (ko) 2012-11-01
CN102665680A (zh) 2012-09-12
EA021604B1 (ru) 2015-07-30
EA201290374A1 (ru) 2013-01-30
IL220534A0 (en) 2012-08-30
EP2515854A2 (fr) 2012-10-31
KR101747474B1 (ko) 2017-06-14
MX340264B (es) 2016-07-04
BR112012015336A2 (pt) 2016-03-15
CL2012001668A1 (es) 2012-12-07
CN102665680B (zh) 2014-07-30
HK1174568A1 (en) 2013-06-14
AU2016234894A1 (en) 2016-10-13
CO6551734A2 (es) 2012-10-31
SG181870A1 (en) 2012-07-30
US20210000738A1 (en) 2021-01-07
MX2012006879A (es) 2012-07-04
WO2011076842A2 (fr) 2011-06-30
CA2785317C (fr) 2018-02-27
HRP20140550T1 (hr) 2014-07-18
US20110150783A1 (en) 2011-06-23
TN2012000261A1 (en) 2013-12-12
CA2785317A1 (fr) 2011-06-30
UA106098C2 (uk) 2014-07-25
DK2515854T3 (da) 2014-05-26
US20150306026A1 (en) 2015-10-29
MA33821B1 (fr) 2012-12-03
US10806701B2 (en) 2020-10-20
PL2515854T3 (pl) 2014-08-29
MY156950A (en) 2016-04-15
AU2016234894B2 (en) 2018-02-22
JP2013515695A (ja) 2013-05-09
PE20121467A1 (es) 2012-11-07
NZ600789A (en) 2014-09-26

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